MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number EGIA60AMT

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: egiaushort endogia ultra univ sht stap (lot#: p3g0260); egiaushort endogia ultra univ sht stap (lot#: p3g0261); egiaushort endogia ultra univ sht stap (lot#: unknown) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload was loaded into a representative handle.The clamping mechanism was deformed.The interlock was overridden and the reload was applied to test media.Test media was transected.The reload interlock was tested and found to function properly.It was reported that the black return knob was stiff and did not return.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: ensure that the black return knob on the instrument is pulled back completely and the articulation lever is neutral (0° relative) to the instrument.Cycle the instrument to confirm proper loading of the reload.To do so, squeeze the handle once to close the jaws of the reload.Push the black loop handle all of the way forward or pull back on the black return knob and confirm that the reload jaws open fully.Failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.Shipping wedge printing "do not remove until loaded".It clearly states instructions for proper use of stapler.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a vats (video-assisted thoracoscopic surgery) partial lung resection procedure, at the time of the 5th to 6th firing of lung parenchyma resection, the surgeon attempted to return the black returned knob while the reload was articulated at the maximum.However, the black return knob was stiff and did not return.When the surgeon returned the articulation to straight, the black return knob was able to be pulled little by little, and finally, the jaws were opened and released.The staple line was then checked and no problem with the formation and no leak were noted.Another handle and reload were used to resolve the issue.There as no patient injury.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18411873
• MDR Text Key: 331707181
• Report Number: 1219930-2023-05404
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523003215
• UDI-Public: 10884523003215
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIA60AMT
• Device Catalogue Number: EGIA60AMT
• Device Lot Number: P3B0110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NOTE ON H10.